Phase 2 Breast Cancer Trial, Recruiting NCT04677816 Sponsor: Wake Forest University Health Sciences Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT04677816
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a man or woman who has been diagnosed with invasive breast cancer, confirmed through a tissue biopsy.
  • Your breast cancer has been tested and confirmed as "triple negative," meaning it tests negative (or very low) for estrogen receptors, progesterone receptors, and HER2 protein.
  • You are planning to receive chemotherapy before surgery to treat your breast cancer, or you started that chemotherapy no more than 2 weeks ago.
  • You are reasonably able to carry out daily activities (your doctor has rated your general health and functioning as acceptable for this trial).
  • You are 18 years of age or older.
  • If you are someone who could become pregnant, you agree to use reliable birth control (such as hormonal methods, barrier methods, or abstinence) throughout the study, and you agree to tell your doctor right away if you become pregnant.
  • You are able to understand what the study involves and are willing to sign a consent form agreeing to take part.

Who may not be able to join:

  • You have had kidney stones within the past year.
  • You have a condition called sarcoidosis (a disease involving inflammation in body tissues).
  • Your blood calcium level was too high within the 30 days before starting chemotherapy (confirm with trial site).
  • You have had an allergic reaction to vitamin D or a similar substance in the past.
  • You are currently pregnant, as the effects of high-dose vitamin D on an unborn baby are not fully known.
  • You are currently breastfeeding, as there may be unknown risks to the baby from high-dose vitamin D.
  • You have already received any treatment for this breast cancer, including surgery, radiation, chemotherapy, hormone therapy, or any experimental treatment, before joining the study.
  • You are already taking vitamin D at a dose of 50,000 International Units (IU) once per week.

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Emily H Douglas, MD, Wake Forest University Health Sciences

Phone: 336-713-0031

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
22 October 2021
Est. completion
1 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Pathologic Complete Response (pCR) in Vitamin D Supplementation Group

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov